Effect of a Multi-directional Power Toothbrush on Recession

NCT02530671 | Completed Results

• 1 other identifier: 2011015
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.

Conditions

Gingival Recession

Keywords

multi-directional power toothbrush; manual toothbrush

Outcome Measures

Primary Outcomes (2)

• Gingival Recession at Sites With Preexisting Recessions ≥2mm

  12 months

• Bristle Splay Index (BSI) After a Specific Time-of-use

  A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).

  3, 6, 9 and 12 months

Secondary Outcomes (4)

• Recession at All Buccal Sites

  12 months

• Percentage of Recession Sites Demonstrating a Change of ≥1mm

  12 months

• Pocket Probing Depths at 12months

  12 months

• Comparison of BSI Between Periods

  0-3, 9-12 months

Study Arms (2)

Manual toothbrush

ACTIVE COMPARATOR

ADA reference manual toothbrush

Device: Toothbrushing with manual toothbrush

Power toothbrush

EXPERIMENTAL

Multi-directional power toothbrush

Device: Toothbrushing with power toothbrush

Interventions

Toothbrushing with manual toothbrush DEVICE

Manual toothbrush

Toothbrushing with power toothbrush DEVICE

Power toothbrush

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scorable teeth without orthodontic appliances or crowns and bridges
• at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth)

You may not qualify if:

• evidence of neglected dental health
• periodontitis and/or major hard/soft tissue lesions
• any physical limitations or restrictions potentially interfering with normal oral hygiene
• therapy with any drug within 28 days prior to the study
• pregnancy or breast feeding
• any systematic condition or significant illness

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• Procter and Gamble: collaborator

MeSH Terms

Conditions

Gingival Recession

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Results Point of Contact

• Title: Dr. Sonja Sälzer
• Organization: University Kiel

saelzer@konspar.uni-kiel.de

00494315972810

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sonja Sälzer

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 21, 2015
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2014
• Last Updated: January 1, 2025
• Results First Posted: October 19, 2015

Record last verified: 2024-12